Cryobiopsy for diagnosing mediastinal conditions in Sweden
Official title: Mediastinal Endobronchial Ultrasound Bronchoscopy Cryobiopsy Study In Sweden
Run by Region Skane · NCT06347939 · Data updated 2026-11-12
This study is testing a new biopsy method to see if it helps doctors better diagnose lung and chest conditions like cancer and infections in patients.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Region Skane Academic / other |
| Locations | 2 sites (Lund and 1 other locations) |
| Status | Recruiting |
| Started | April 1, 2024 |
| Main results expected | April 1, 2026 |
| Study ends | December 31, 2028 |
| Registry record updated | July 17, 2025 |
| Trial ID | NCT06347939 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 with mediastinal lymphadenopathy greater than 1 cm who require sampling for diagnosis.
✕Probably not a fit
Patients with severe health conditions such as respiratory failure or high bleeding risk may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study evaluates the effectiveness of Endobronchial UltraSound TransBronchial Mediastinal CryoBiopsy (EBUS TBMCB) in diagnosing mediastinal lymphadenopathy, lung cancer, sarcoidosis, lymphoma, and tuberculosis. Participants will undergo EBUS TBNA and EBUS TBMCB procedures, with their biopsy samples compared to assess the diagnostic yield of each method. The study aims to determine how many biopsies are necessary to achieve a definitive diagnosis and to evaluate the added value of combining EBUS TBMCB with EBUS TBNA. Follow-up assessments will occur four weeks post-procedure to monitor for any complications.
Why it matters
Potential benefit: If successful, this study could improve diagnostic accuracy for patients with mediastinal conditions, leading to better-targeted treatments.
How similar studies have gone: Previous studies have shown promising results for EBUS TBMCB, indicating its potential effectiveness in improving diagnostic yield.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Mediastinal lymphadenopathy with a diameter greater than 1 cm. * Indication for assessment and sampling according to clinical praxis * Age \> 18 years * Patients consent to participate in the study. Exclusion Criteria: * Hemodynamically instable patient * Myocardial infarction in the last six weeks prior to participating in the study. * Life threatening arrythmia * Respiratory failure and inadequate blood oxygenation despite oxygen supply. * Tracheal obstruction of high grade. * High bleeding risk * Patient not willing to participate in the study * Patient not speaking swedish and needing translator during the procedure
Where it's running
-
Respiratory medicine and allergy department, Skåne University Hospital
Lund, Sweden Recruiting -
Norrlands universitetssjukhus
Umeå, Sweden Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.